GENCONTUSS
- Product NDC
- 52083-650
- 11-digit product format
- 520830650
- Labeler code
- 52083
- Product ID
- 52083-650_8a52f9ca-43f9-4f88-ae67-2ee6e1541d51
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- KRAMER NOVIS
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-06-08
- Substance
- CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 2; 10; 5 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52083-650-16 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52083-650-16 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52083-650-16 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52083-650-16 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52083-650-16 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52083-650-16 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52083-650-16 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52083-650-16 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GENCONTUSS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 2 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1363752 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 69d16d25-b09b-430e-8e01-0962d840dc21 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-11-14 | GENCONTUSS |
| 2025-11-14 | GENCONTUSS ® |
| 2025-01-30 | GENCONTUSS |
| 2025-01-30 | GENCONTUSS ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-650-16 | GENCONTUSS | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-650-16 | ML - Milliliter | 52083-650 | 06ae7d11-09ed-4531-ad88-041ec9f515c2 | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52083-650 | GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20221029_69d16d25-b09b-430e-8e01-0962d840dc21.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TheraCare Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | d6e789c7-a55a-dc9a-e053-2a95a90a2bdb | 2024-10-29 | Warnings | M012 |
| Careone daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | American Sales Company | 31187c98-6706-4962-91f6-022a390cda39 | 2024-10-28 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 0100f86e-257f-4197-9849-3c4429cdf0f2 | 2024-10-28 | Warnings | M012 |
| Premier Value Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 46bf124a-a44f-4066-b936-852d46da8f40 | 2024-10-28 | Warnings | M012 |
| Signature Care Non drowsy Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | 25a26577-a9f8-49cb-9d75-d8c471e4aaf6 | 2024-10-28 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e | 2024-10-28 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | d38537c6-9553-4e93-a83e-11ed48c955ab | 2024-10-28 | Warnings | M012 |
| Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 2b3a1997-f382-4843-a44b-d80d1ad21a90 | 2024-10-28 | Warnings | M012 |
| Premier Value Tussin Cough Long Acting | DEXTROMETHORPHAN HBR | Chain Drug Consortium, LLC | 0e393287-5bb8-458b-98c4-55fa16674d06 | 2024-10-28 | Warnings | M012 |
| daytime cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1740ccfc-6e68-46f4-a1ba-48fe092f0aa0 | 2024-10-28 | Warnings | M012 |
| night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | d3bd0632-328c-4ad7-bb44-8383e1e51b8c | 2024-10-28 | Warnings | M012 |
| Premier Value | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 1ae3c6ac-1646-4c67-a9d5-9c383924b81a | 2024-10-28 | Warnings | M012 |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 2024-10-25 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | b6d9f421-b236-4660-be7f-85a878f2fc61 | 2024-10-25 | Warnings | M012 |
| COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | f9c3c12b-4efa-4ec4-a156-c403aff81753 | 2024-10-24 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | 1deb60f3-e9be-4756-b0c1-527ef00dc741 | 2024-10-24 | Warnings | M012 |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | 51dd467b-aae8-41fa-e054-00144ff8d46c | 2024-10-24 | Warnings | M012 |
| Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 68a5930b-37db-439d-8fb9-7d7de07d8465 | 2024-10-24 | Warnings | M012 |
| sinus pressure pain and cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | bb0225d5-6c32-2c64-e053-2995a90a829b | 2024-10-24 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148 | 2024-10-24 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1363752 | chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution | PSN | 69d16d25-b09b-430e-8e01-0962d840dc21 | 7 |
| 1363752 | chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 69d16d25-b09b-430e-8e01-0962d840dc21 | 7 |
| 1363752 | chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 69d16d25-b09b-430e-8e01-0962d840dc21 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-650-16 | 52083065016 | 473 mL in 1 BOTTLE, PLASTIC (52083-650-16) | 473 ml | 2015-06-08 | 0000-00-00 | No | No | Current |